Optimisation of the Treatment of Infectious Bursitis

Not Applicable

Completed

• Conditions: Olecranon Bursitis; Patellar Bursitis
• Interventions: Procedure: Two-stage bursectomy

• Registration Number: NCT01406652
• Lead Sponsor: University Hospital, Geneva

Brief Summary

The study investigates prospectively the cost-savings related to a one-stage bursectomy (debridement, drainage and closure at the same time) versus two-stage bursectomy (debridement, left open and closure at a second time) of severe bursitis among hospitalized patients for surgical treatment of septic bursitis.

We suppose that the one-stage bursectomy reveals similar recurrence rates but is associated with a significant shortening of hospital stay, consumption of resources and increased patient satisfaction.

Detailed Description

Start as single center interventional study at Geneva University Hospitals Study open for additional centres (electronic CRF) Funding on 24.6.2011 (50,000 Swiss Francs). Further demand for funding ongoing.

Septic bursitis of knee and elbows, for which the patients are hospitalised (a substantial part of patient with failure of conservative treatment) Randomisation 1:1 (one-stage vs. two-stage).

Duration of concomitant postsurgical antibiotic therapy fixed to 7 days Exclusion of severely immuno-depressed patients.

Assessment of all costs of inpatient treatment and outpatient follow-up of included cases.

Interim analysis after ca. 100 cases planified.

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-06-27
• Study First Submitted QC: 2011-07-29
• Study First Posted: 2011-08-01
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Results First Submitted: 2017-01-16
• Status Verified: 2019-11
• Results First Submitted QC: 2019-11-01
• Results First Posted: 2019-11-05
• Last Update Submitted: 2019-11-27
• Last Update Posted: 2019-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 224

Inclusion Criteria

1. Age >18 years
2. Hospitalized for bursectomy for septic bursitis

Exclusion Criteria

1. Bacteraemic diseases
2. Presence of another concomitant infection requiring antibiotics
3. Presence of osteosynthesis material beneath the bursitis
4. Septic bursitis outside of the elbow or the knee
5. Severe immune suppression (transplantation, HIV with Cluster of Differentiation cell count <200 cells/mm3, immune suppressive treatment with equivalence of more than 15 mg of prednisone daily ).
6. Recurrent septic bursitis episodes

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Two-stage bursectomy	Two-stage bursectomy	Bursectomy with debridement and left open. Wound closure in a second step and in a second surgery.
One-stage bursectomy	Two-stage bursectomy	Bursectomy with debridement and primary closure of the wound during one surgical intervention

Primary Outcome Measures

Name	Time	Method
Overall Costs of the Combined Surgical and Medical Treatment	2 months	The overall costs are of primary interest in the study protocol.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Post-surgical Wound Dehiscence	2 months	We assess clinical failures of bursectomy for bursitis. As recurrences are associated with wound dehiscence, we evaluate the dehiscence a the most important parameter for Failure. Of course, dehiscence can also occur without recurrent infection, but this is also considered as failure.

Trial Locations

Locations (1)

Geneva University Hospitals; 🇨🇭 Geneva, Switzerland